Recruiting PHASE2 Obesity in Pregnancy

New treatment option for Obesity in Pregnancy

Official title Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0

ClinicalTrials.gov ID: NCT06488781

What this study is testing

What is Azithromycin?

Azithromycin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for obesity in pregnancy.

Also referred to as Cefazolin.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Obesity increases the risk of pregnancy complications, including puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Since obese women are more likely to have comorbidities that would necessitate delivery prior to their due date (i.e.
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 15 to 45, women only

You may be able to join if

  • BMI ≥30
  • No prior deliveries at or beyond 20 weeks gestation
  • Undergoing induction of labor
  • Gestational age 37 weeks or more
  • Age 15-45

You likely can't join if

  • Fetal death prior to labor induction
  • Known fetal anomaly
  • Multiple gestation
  • Ruptured membranes for more than 12 hours
  • Chorioamnionitis or other infection requiring antibiotics at the start of the labor induction
  • Previous myometrial surgery
See the full eligibility criteria
Who can join
  • BMI ≥30
  • No prior deliveries at or beyond 20 weeks gestation
  • Undergoing induction of labor
  • Gestational age 37 weeks or more
  • Age 15-45
  • Not receiving IAP for GBS prophylaxis
What rules you out
  • Fetal death prior to labor induction
  • Known fetal anomaly
  • Multiple gestation
  • Ruptured membranes for more than 12 hours
  • Chorioamnionitis or other infection requiring antibiotics at the start of the labor induction
  • Previous myometrial surgery
  • Allergy to azithromycin or beta-lactam antibiotics

The study team makes the final eligibility decision.

Where it's taking place

  • Oklahoma City, Oklahoma, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 15 years to 45 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.